BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8922020 · Received August 22, 2019

    Report

    Report Number
    3013756811-2019-52075
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    July 30, 2019
    Report Date
    August 22, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER EXPERIENCED CONNECTION ISSUES BETWEEN THE PUMP AND THE TRANSMITTER. MULTIPLE ATTEMPTS WERE MADE BY TANDEM¿S TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION REGARDING THIS EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714876 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR